BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040632 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00599
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 1, 2012
    Report Date
    June 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED THAT THE TRILUMEN INSULATION WAS DAMAGED BETWEEN 330 AND 345 MILLIMETERS (MM) FROM THE TIP THROUGH TO THE PROXIMAL AND DISTAL HIGH VOLTAGE LUMEN. THERE WAS TRILUMEN INSULATION WEBBING DAMAGE BETWEEN ALL THREE LUMENS IN THIS AREA. THE GORE COVERING ON THE PROXIMAL HV DBS AND THE RS- CONDUCTOR COIL APPEARS ABRADED/TORN IN THIS AREA. MICROSCOPIC ANALYSIS INDICATES THE INSULATION DAMAGE WAS INITIATED BY A LOCALIZED COMPRESSIVE STRESS ON THE TUBING SURFACE. THE INSULATION IS FLATTENED. ANALYSIS CONCLUDED THAT, DUE TO THE LOCATION AND TYPE OF DAMAGE, IT IS LIKELY THIS WAS CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY BEING ANALYZED. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD UNDERWENT A POCKET REVISION PROCEDURE DUE AN INFECTION. APPROXIMATELY ONE YEAR LATER, THE DEVICE HAD MIGRATED TOWARDS THE ARM PIT. THE POCKET WAS NOTED TO BE RED AND SWOLLEN AND THE DEVICE WAS STICKING OUT AT AN ANGLE; HOWEVER, IT WAS NOT ERODING OUT OF THE SKIN. ANOTHER POCKET REVISION WAS PERFORMED AND THE SAME DEVICE WAS MOVED MORE MEDIALLY AND BLOOD CULTURES WERE TAKED TO DETERMINE IF AN INFECTION WAS PRESENT. THE LEAD REMAINS IMPLANTED AT THIS TIME. ADDITIONAL INFORMATION INDICATED THAT THE FIELD REPRESENTATIVE HAS NOT RECEIVED THE RESULTS OF THE CULTURES TAKEN. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE RV LEAD HAD ERODED THROUGH THE SKIN. IT WAS NOTED THAT THE PATIENT HAS HAD AN INFECTION FOR ABOUT A YEAR NOW AND WENT TO A PLASTIC SURGEON WHO HOPED TO BURY THE DEVICE UNDER THE MUSCLE AND CLEAR UP THE SKIN INFECTION. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143534 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 4469| N118| H175| 4517| 0184